MAUDE Adverse Event Report: ALERE SAN DIEGO, INC FISHER-SURE-VUE HCG STAT SRM/URINE (50T); PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4).Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: the customer's observation was not replicated in-house with retention devices.Retention devices were tested with in-house clinical hcg negative urine samples.All hcg results were negative at read time and met qc specifications.No false positive results were obtained during in-house testing.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined based on the information provided.Customer unwilling to return/unresponsive.

Event Description

Unspecified date: patient presented to facility for an unspecified reason.False positive result obtained 2x on the fisher sure-vue hcg stat serum/urine kit.Confirmatory serum quant was performed and the result was negative.Exact result not provided.The customer stated there may have been a delay in treatment of about an hour at the most as they waited for the serum quant result.No adverse outcomes reported due to the false positive result on the fisher sure-vue hcg stat serum/urine hcg-stat kit or the delay in treatment.Customer unable to confirm why the patient was being tested on the fisher sure-vue hcg stat serum/urine kit.The customer stated it is their regular procedure to perform a pregnancy test on women who are at a childbearing age prior to any imaging or procedures.No further information provided.

• Brand Name: FISHER-SURE-VUE HCG STAT SRM/URINE (50T)
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 9127139
• MDR Text Key: 189733332
• Report Number: 2027969-2019-00519
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: FHC-A202
• Device Catalogue Number: 23900531
• Device Lot Number: HCG8040087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1